Recall Z-2153-2017— Innovasis, Inc
Class II · Terminated
Class II FDA medical device recall by Innovasis, Inc, initiated 2017-05-05, terminated 2017-08-01. It names one FDA 510(k) clearance: K061147. Product: Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.. Reason: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14)..
- Recalling firm
- Innovasis, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-05
- Terminated
- 2017-08-01
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
Reason for recall
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Data sourced from openFDA. This site is unofficial and independent of the FDA.